Cocamide DEA vs Permethrin for Head Lice

Pediculosis Capitis Clinical Trial

Official title: A Randomised, Controlled, Assessor-blind, Parallel Group Clinical Trial to Assess the Efficacy, Safety and Acceptability of a Surfactant Based Lotion and a Permethrin Creme Rinse in the Treatment of Head Lice

Status Terminated

Clinical Trial Summary

To assess the efficacy and safety of 10% Cocamide DEA and Lyclear creme rinse (permethrin1%) in the eradication of head lice. To assess the ability of each product to kill all viable ova and to assess patient acceptability of the product in use.

Clinical Trial Description

A formulation of cocamide diethanolamine (DEA) surfactant was previously reported as showing efficacy to eliminate head louse infestation. This study has been designed to test those data using a new formulation of 10% cocamide DEA in an aqueous basis in comparison with the standard of care product 1% permethrin creme rinse. It is believed that surfactants like cocamide DEA are capable of eliminating lice resistant to conventional insecticides.

A planned total of 120 patients who, following examination, are found to suffer from active head lice infestation will be recruited to the trial. The patient will be treated with the appropriate product according to the randomization code from a pre-prepared listing in balanced blocks of 12.

10% Cocamide DEA is applied directly to dry hair and is washed off with shampoo after 60 minutes. Permethrin 1% creme rinse is applied to shampooed and towel dried hair and left in situ for 10 minutes, then rinsed off with clean water. Treatments will be applied by experienced investigators throughout the study. Assessments will be made by other investigators unaware of the treatment regimen used.

After treatment (day 0), follow up assessments will be performed on days 4, 7,10 then again at day 14 after which they will leave the study. Any adverse events or side effects from the treatments will be monitored during the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Louse Infestation
• Lice Infestations
• Pediculosis Capitis

• NCT number: NCT02500524
• Study type: Interventional
• Source: Medical Entomology Centre
• Status: Terminated
• Phase: Phase 3
• Start date: July 1998
• Completion date: January 1999